Healthy Diet for High Blood Pressure

(GoFresh Trial)

Recruiting at 1 trial location

Overseen By Stephen P Juraschek, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Antihypertensives, SGLT2 inhibitors, Stimulants, others

Disqualifiers: Diabetes, Cardiovascular disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

150 Participants Needed

Trial Summary

What is the purpose of this trial?

GoFresh is a randomized trial, testing the effects of a home-delivered DASH-patterned grocery intervention on blood pressure in Black adults, residing in Boston area urban food deserts.

Will I have to stop taking my current medications?

If you are taking any medications that lower blood pressure or are intended for hypertension treatment, you must have stopped them at least 6 months before joining the trial. Additionally, if you are on certain other medications like potassium supplements, warfarin, or chronic oral corticosteroids, you may not be eligible to participate.

What data supports the effectiveness of the treatment Dietitian-Assisted DASH groceries, DASH Diet, Dietary Approaches to Stop Hypertension, DASH Eating Plan, Self-directed shopping for high blood pressure?

Research shows that the DASH diet, which includes lots of fruits, vegetables, and lean proteins while reducing salt and unhealthy fats, is effective in lowering high blood pressure. It also helps with other health issues like diabetes and heart disease risk factors. ^{1 2 3 4 5}

Is the DASH diet safe for people with high blood pressure?

The DASH diet, which is rich in fruits, vegetables, and low-fat dairy, is generally safe for most people and can help lower blood pressure. However, people with certain conditions like chronic kidney or liver disease should be cautious and may need to modify the diet. ^{1 2 6 7 8}

How is the DASH diet treatment different from other treatments for high blood pressure?

The DASH diet treatment is unique because it focuses on a balanced eating plan that includes high consumption of fruits, vegetables, and lean proteins while reducing salt, red meat, and fat intake. Unlike medications, it not only helps lower blood pressure but also improves other health factors like cholesterol levels and insulin resistance, making it beneficial for overall cardiovascular health. ^{2 3 8 9 10}

Research Team

Stephen P Juraschek, MD, PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for Black adults living in certain Boston areas without treated hypertension, with systolic blood pressure between 120-149 mm Hg and diastolic below 100 mm Hg. Participants must be able to receive and consume only provided groceries for 12 weeks, have kitchen facilities, Wi-Fi/cell service, and a device for grocery orders. Exclusions include severe health conditions like diabetes or recent cardiovascular events, significant weight changes recently, extreme diets or food insecurities.

Inclusion Criteria

Residence in communities identified as Boston area food deserts: Brighton, Chelsea, Dorchester, East Boston, Everett, Hyde Park, Jamaica Plain, Malden, Mattapan, Revere, Roslindale, Roxbury, or Winthrop

Have access to refrigeration, cooking appliances, and Wi-Fi/cellular service

I can get groceries delivered or pick them up and will only eat these for 12 weeks.

Exclusion Criteria

Arm circumference >50cm

I have lost or gained more than 5% of my weight in the last 2 months.

I am not taking potassium supplements, warfarin, chronic steroids, or weight loss drugs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either dietitian-assisted DASH grocery delivery or a monthly stipend for self-directed shopping over a 12-week period

12 weeks

Weekly virtual or phone sessions for grocery orders

Observation

Participants are monitored for maintenance of dietary changes without the provision of groceries or stipend

9 months

In-person assessments at 3 months, phone visit at 9 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

In-person assessments and qualitative interviews

Treatment Details

Interventions

• Dietitian-Assisted DASH groceries
• Self-directed shopping

Trial Overview The GoFresh trial is examining if home-delivered DASH-patterned groceries can lower blood pressure among Black adults in urban food deserts of Boston. It's a randomized study where some will get dietitian-assisted shopping while others will shop on their own.

Participant Groups

Group I: Dietitian-Assisted DASH groceries Experimental Treatment 1 Intervention

Participants will order groceries sufficient to meet their caloric needs each week for 12 weeks with the assistance of a dietitian/nutrition interventionist. Groceries will be delivered to participants' homes or picked up at a convenient location. The dietitian/nutrition interventionist will provide brief educational content at the time of food delivery. Orders will be placed via phone or through virtual counseling sessions. During the remainder of the study (months 4-12), participants will be asked to apply what they learned without the provision of groceries.

Group II: Self-directed shopping (referent assignment) Active Control 1 Intervention

Participants will receive a monthly stipend over a 3 month period and some basic information about healthy eating. The stipend is not restricted to foods. During the remainder of the study (months 4-12), participants will be asked to continue their typical shopping without the provision of the monthly stipend.

Dietitian-Assisted DASH groceries is already approved in United States, Canada, European Union for the following indications:

Approved in United States as DASH Diet for:

• Hypertension
• High Blood Pressure

Approved in Canada as DASH Diet for:

• Hypertension
• High Blood Pressure

Approved in European Union as DASH Diet for:

• Hypertension
• High Blood Pressure

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Findings from Research

The DASH diet, which focuses on fruits, vegetables, low-fat dairy, whole grains, nuts, fish, and poultry while reducing fats and sugars, has been shown to effectively lower blood pressure, as demonstrated in the DASH clinical trial.

Healthcare practitioners, including dietitians, play a crucial role in helping individuals adopt the DASH diet by addressing ambivalence, enhancing motivation, and providing tailored dietary advice to fit personal lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the Dietary Approaches to Stop Hypertension diet from research to practice: dietary and behavior change techniques. DASH Collaborative Research Group. Windhauser, MM., Ernst, DB., Karanja, NM., et al.[2019]

A study of 2,831 adults in Iran found that adherence to the DASH diet is associated with lower levels of cardiovascular risk factors, including blood pressure, fasting blood sugar, triglycerides, and cholesterol.

Specifically, individuals in the highest quintile of DASH diet adherence had a 28% lower odds of hyperglycemia, suggesting that the DASH diet may be effective in reducing the risk of diabetes and other cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association between DASH Diet Adherence and Cardiovascular Risk Factors. Shoaibinobarian, N., Danehchin, L., Mozafarinia, M., et al.[2023]

The DASH eating plan is beneficial for people with diabetes, as it not only helps control blood pressure but also improves insulin resistance and reduces high cholesterol levels.

This diet encourages a variety of healthy foods, making it suitable for the whole family and effective in managing weight and obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DASH Eating Plan: An Eating Pattern for Diabetes Management. Campbell, AP.[2020]

In a study of 144 overweight or obese adults with high blood pressure, those following the DASH diet alone or with weight management experienced significant reductions in blood pressure compared to those on a usual diet, highlighting the diet's efficacy as a nonpharmacologic treatment.

Greater adherence to the DASH diet was linked to larger decreases in blood pressure, and the study found that African Americans had lower adherence rates, suggesting the need for culturally tailored dietary strategies to improve compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants and consequences of adherence to the dietary approaches to stop hypertension diet in African-American and white adults with high blood pressure: results from the ENCORE trial. Epstein, DE., Sherwood, A., Smith, PJ., et al.[2022]

The DASH diet is effective in lowering blood pressure, but studies show that compliance with the diet is often suboptimal, especially in educational interventions compared to controlled feeding trials.

There is no consensus on the best method to assess compliance with the DASH diet, highlighting the need for more effective strategies to maintain adherence beyond just dietary counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. Kwan, MW., Wong, MC., Wang, HH., et al.[2023]

The DASH diet, which emphasizes fruits, vegetables, and low-fat dairy, has been shown to effectively lower blood pressure in individuals with prehypertension and stage I hypertension, based on findings from the DASH trial.

While the DASH diet is generally safe for most patients, caution is advised for those with chronic kidney or liver diseases, and modifications may be needed for individuals with chronic heart failure, uncontrolled diabetes, lactose intolerance, or celiac disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. Tyson, CC., Nwankwo, C., Lin, PH., et al.[2021]

The DASH diet, which emphasizes fruits, vegetables, nuts, and low-fat dairy while reducing saturated fats, led to an average reduction of 6 mmHg in systolic and 3 mmHg in diastolic blood pressure among patients, with even greater reductions in those with high blood pressure.

These significant blood pressure reductions were observed within just 2 weeks of starting the diet, indicating its potential effectiveness for managing hypertension in a primary care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Approaches to Stop Hypertension (DASH) in clinical practice: a primary care experience. Kolasa, KM.[2020]

Following the DASH diet, which is rich in fiber, nutrients, and antioxidants, is linked to a lower prevalence of various cancers, suggesting it may have protective effects against cancer development.

While this review indicates a positive association between the DASH diet and cancer prevention, further longitudinal studies are needed to clarify the exact relationship due to the complex interactions among different foods and nutrients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary approach to stop hypertension (DASH): diet components may be related to lower prevalence of different kinds of cancer: A review on the related documents. Onvani, S., Haghighatdoost, F., Azadbakht, L.[2020]

The HF-DASH diet, which substitutes full-fat for low-fat dairy and reduces sugar intake, effectively lowers blood pressure similarly to the standard DASH diet while also reducing triglycerides and VLDL particle concentrations.

While both the DASH and HF-DASH diets lowered blood pressure, only the standard DASH diet significantly reduced LDL cholesterol and other harmful lipoproteins compared to a control diet, suggesting that the HF-DASH diet may be a safer alternative without compromising blood pressure benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the DASH (Dietary Approaches to Stop Hypertension) diet and a higher-fat DASH diet on blood pressure and lipids and lipoproteins: a randomized controlled trial. Chiu, S., Bergeron, N., Williams, PT., et al.[2023]

In a study of 412 adults with pre- or stage 1 hypertension, combining a low sodium diet with the DASH diet resulted in significant reductions in systolic blood pressure (SBP), especially in individuals with higher baseline SBP levels (≥150 mm Hg), where reductions reached up to -20.8 mm Hg.

Reducing sodium intake alone also lowered SBP across all baseline levels, indicating that both dietary interventions are effective in managing blood pressure, with the most pronounced effects observed in those with higher initial blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Sodium Reduction and the DASH Diet in Relation to Baseline Blood Pressure. Juraschek, SP., Miller, ER., Weaver, CM., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Translating the Dietary Approaches to Stop Hypertension diet from research to practice: dietary and behavior change techniques. DASH Collaborative Research Group. [2019]

2. Iran pubmed.ncbi.nlm.nih.gov

The Association between DASH Diet Adherence and Cardiovascular Risk Factors. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

DASH Eating Plan: An Eating Pattern for Diabetes Management. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Determinants and consequences of adherence to the dietary approaches to stop hypertension diet in African-American and white adults with high blood pressure: results from the ENCORE trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Dietary Approaches to Stop Hypertension (DASH) in clinical practice: a primary care experience. [2020]

8. India pubmed.ncbi.nlm.nih.gov

Dietary approach to stop hypertension (DASH): diet components may be related to lower prevalence of different kinds of cancer: A review on the related documents. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Comparison of the DASH (Dietary Approaches to Stop Hypertension) diet and a higher-fat DASH diet on blood pressure and lipids and lipoproteins: a randomized controlled trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of Sodium Reduction and the DASH Diet in Relation to Baseline Blood Pressure. [2022]